PediculosisPhase 1NCT05643820
Comparison of Oral Ivermectin and Permethrin 5% Lotion in Treatment of Pediculosis Capitis
A Phase 1 study testing Permethrin 5% topical lotion and Ivermectin in people with Pediculosis, run by Combined Military Hospital Abbottabad at 1 site in Pakistan.
Trial summary
In children, pediculosis is a common ectoparasitic infestation. Infestation of head lice (Pediculus humanus capitis) causes a variety of physical symptoms, including pruritus, excoriation, cervical lymphadenopathy, and conjunctivitis1. Read more about this study
- Who is it for?
- Ages 8 to 36 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediculosis
- What is being tested?
- Permethrin 5% topical lotion and Ivermectin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2022to 31 Aug 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 36 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- both genders with live detected on clinical examination and by combing wet hair with a fine toothed lice detection comb ages 8-36 years weight >15 kgs
Who cannot join
- pregnancy breast feeding using any pediculicidal medication within the preceding two weeks of treatment hairstyle that may be difficult to comb
Trial locations and contacts
1 site in 1 country.
About this study
In children, pediculosis is a common ectoparasitic infestation. Infestation of head lice (Pediculus humanus capitis) causes a variety of physical symptoms, including pruritus, excoriation, cervical lymphadenopathy, and conjunctivitis1. It also has a number of negative social consequences, including parental anxiety and stigmatization of infested children2.
It is a significant public health issue that primarily affects school-aged children aged 8 to 113. In developing nations, prevalence rates of up to 40% have been reported4. The four urban areas of KPK (NWFP) reported prevalence of 36.7%5. People with a low socioeconomic background and poor hygiene are more likely to be affected6.
Read more
Pediculosis capitis has been treated using a variety of treatment modalities. They include both physician prescription and over-the-counter medications. Permethrin or ivermectin had been used topically or orally. Permethrin is a neurotoxin that is synthesized. It is a pyrethroid neurotoxic that targets voltage-sensitive Sodium ion receptors in the neurological system of the insect, triggering nerve depolarization, hyperexcitation, muscular paralysis, and, eventually, parasite death7. Ivermectin is antiparasitic medication, it is possible to treat diseases like lymphatic filariasis, and ectoparasite infestations, primarily scabies, with ivermectin because it binds to glutamate gated chloride ion receptors of invertebrates and disrupts neurotransmission8.
The rationale of this study is to study while comparing effectiveness of oral ivermectin and topical permethrin in management of pediculosis. The topical medication usage is problematic and had reported drug resistance9. There has been less regional or national research on the effectiveness of oral Ivermectin, so doctors less frequently use it in our department. Instead, the patients are treated for pediculosis capitis with topical Permethrin.
- Conditions
- Pediculosis
- Being tested
- Permethrin 5% topical lotion, Ivermectin
- Keywords
- ivermectin, permethrin 5% lotion
- Medical subject headings
- Lice Infestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Permethrin 5% topical lotionDrug
patients in group A prescribed with 5% topical permethrin lotion two overnight applications seven days apart
IvermectinDrug
patients in group B and weighing more than 15 kgs were given oral ivermectin 200 microgram/kg two doses seven days apart
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Patients prescribed with topical 5% Permethrin lotion two applications seven days apart and applied overnight. Receives: Drug: Permethrin 5% topical lotion |
| group B | Active comparator | Patients weighing greater than 15kgs prescribed with oral ivermectin 200microgram/kg two doses seven days apart Receives: Drug: Ivermectin |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison of oral ivermectin and 5%permethrin lotion the treatment of pediculosis capitis assessed after two applications seven days apart and reassessed at 14 days
treatment was considered to be effective with complete absence of symptoms i.e pruritus and the absence of live lice after combing wet hair with a fine toothed detection comb
Measured: 06 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study start1 Mar 2022
- Primary completion31 Aug 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PediculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Combined Military Hospital Abbottabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huma Farid, Combined Military Hospital Abbottabad
- Investigators
- Bushra Muzaffar, FCPS, Principal investigator, Combined Military Hospital Abbottabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05643820
- Sponsor's protocol ID
- CMHAtd-ETH-21-Derm-22
- Status last verified
- Dec 2022
- First submitted
- 22 Nov 2022
- Last updated
- 9 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Oral Ivermectin and Permethrin 5% Lotion in Treatment of Pediculosis Capitis
- ClinicalTrials.gov ID
- NCT05643820
- Acronym / sponsor ID
- CMHAtd-ETH-21-Derm-22
- Conditions
- Pediculosis
- Keywords
- ivermectin, permethrin 5% lotion
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Combined Military Hospital AbbottabadUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 9 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In children, pediculosis is a common ectoparasitic infestation. Infestation of head lice (Pediculus humanus capitis) causes a variety of physical symptoms, including pruritus, excoriation, cervical lymphadenopathy, and conjunctivitis1. It also has a number of negative social consequences, including parental anxiety and stigmatization of infested children2.
It is a significant public health issue that primarily affects school-aged children aged 8 to 113. In developing nations, prevalence rates of up to 40% have been reported4. The four urban areas of KPK (NWFP) reported prevalence of 36.7%5. People with a low socioeconomic background and poor hygiene are more likely to be affected6.
Pediculosis capitis has been treated using a variety of treatment modalities. They include both physician prescription and over-the-counter medications. Permethrin or ivermectin had been used topically or orally. Permethrin is a neurotoxin that is synthesized. It is a pyrethroid neurotoxic that targets voltage-sensitive Sodium ion receptors in the neurological system of the insect, triggering nerve depolarization, hyperexcitation, muscular paralysis, and, eventually, parasite death7. Ivermectin is antiparasitic medication, it is possible to treat diseases like lymphatic filariasis, and ectoparasite infestations, primarily scabies, with ivermectin because it binds to glutamate gated chloride ion receptors of invertebrates and disrupts neurotransmission8.
The rationale of this study is to study while comparing effectiveness of oral ivermectin and topical permethrin in management of pediculosis. The topical medication usage is problematic and had reported drug resistance9. There has been less regional or national research on the effectiveness of oral Ivermectin, so doctors less frequently use it in our department. Instead, the patients are treated for pediculosis capitis with topical Permethrin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: Permethrin 5% topical lotionPatients prescribed with topical 5% Permethrin lotion two applications seven days apart and applied overnight. |
| group B | Active comparator | Drug: IvermectinPatients weighing greater than 15kgs prescribed with oral ivermectin 200microgram/kg two doses seven days apart |
Who may qualify
- Ages
- 8 to 36 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- both genders with live detected on clinical examination and by combing wet hair with a fine toothed lice detection comb ages 8-36 years weight >15 kgs
Key exclusion criteria (1 listed)
- pregnancy breast feeding using any pediculicidal medication within the preceding two weeks of treatment hairstyle that may be difficult to comb
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Permethrin 5% topical lotionpatients in group A prescribed with 5% topical permethrin lotion two overnight applications seven days apart | Drug | Group A |
| Ivermectinpatients in group B and weighing more than 15 kgs were given oral ivermectin 200 microgram/kg two doses seven days apart | Drug | group B |
Primary outcome
comparison of oral ivermectin and 5%permethrin lotion the treatment of pediculosis capitis assessed after two applications seven days apart and reassessed at 14 days
Time frame: 06 months
treatment was considered to be effective with complete absence of symptoms i.e pruritus and the absence of live lice after combing wet hair with a fine toothed detection comb
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2022.
Related trials for Pediculosis
Recruiting
Safety, Efficacy and Preventative Effect of a Head Lice Product (X92001483) vs. Nix Creme Rinse (1% Permethrin).
Lice; Head Lice
Not yet recruiting
Comparative Study for the Evaluation of a New Medical Device Shampoo on the Treatment of Head Lice Infestation
Headlice
Not yet recruiting
Efficacy and Safetyof a Medical Device With a Physical Mode of Action (X92001919) Versus Paranix Anti-lice Shampoo.
Lice; Head Lice
Recruiting
Safety and Efficacy of Head-lice Treatments Elimax Green Lotion and Walgreens Lice Killing Shampoo
Head Lice
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bushra Muzaffar, FCPS principal investigator
Combined Military Hospital Abbottabad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Permethrin 5% topical lotion and Ivermectin in people with Pediculosis, run by Combined Military Hospital Abbottabad at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparison of oral ivermectin and 5%permethrin lotion the treatment of pediculosis capitis assessed after two applications seven days apart and reassessed at 14 days (time frame: 06 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2022.